Device recall: Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106

FDA enforcement event 82642 · Class II · initiated 8 Apr 2019 · status Terminated · terminated 11 May 2020

DeviceVoluntary: Firm initiated76 product recordsWinterthur, N/A

FDA enforcement event 82642 is a device recall by Zimmer GmbH of Winterthur, N/A, initiated 8 Apr 2019 and classified Class II, with 76 product records.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 11 May 2020. Initiation: voluntary: firm initiated. Zimmer GmbH has 14 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Zimmer GmbH, Winterthur, N/A, Switzerland.

Reason for recall

"An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications."

Distribution

"The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1413-2019	Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106	N/A	Class II	Terminated	29 May 2019
Z-1414-2019	Drill Sys2.7, 2x103mm, AO, Item Number 502015107	N/A	Class II	Terminated	29 May 2019
Z-1415-2019	Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114	N/A	Class II	Terminated	29 May 2019
Z-1416-2019	Drill, 15mm stop, 1x76mm, AO , Item Number 502015115	N/A	Class II	Terminated	29 May 2019
Z-1417-2019	Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120	N/A	Class II	Terminated	29 May 2019
Z-1418-2019	Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124	N/A	Class II	Terminated	29 May 2019
Z-1419-2019	Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130	N/A	Class II	Terminated	29 May 2019
Z-1420-2019	Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131	N/A	Class II	Terminated	29 May 2019
Z-1421-2019	Drill, 2.5x94mm, Stryker, Item Number 502015136	N/A	Class II	Terminated	29 May 2019
Z-1422-2019	Drill, 2.5x87mm, AO, Item Number 502015137	N/A	Class II	Terminated	29 May 2019
Z-1423-2019	Drill, 2.5x135mm, AO, Item Number 502015142	N/A	Class II	Terminated	29 May 2019
Z-1424-2019	Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145	N/A	Class II	Terminated	29 May 2019
Z-1425-2019	Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015146	N/A	Class II	Terminated	29 May 2019
Z-1426-2019	Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206	N/A	Class II	Terminated	29 May 2019
Z-1427-2019	Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207	N/A	Class II	Terminated	29 May 2019
Z-1428-2019	Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208	N/A	Class II	Terminated	29 May 2019
Z-1429-2019	Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211	N/A	Class II	Terminated	29 May 2019
Z-1430-2019	Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212	N/A	Class II	Terminated	29 May 2019
Z-1431-2019	Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213	N/A	Class II	Terminated	29 May 2019
Z-1432-2019	Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216	N/A	Class II	Terminated	29 May 2019
Z-1433-2019	Drill, 2.7x125mm, AO, Item Number 502015217	N/A	Class II	Terminated	29 May 2019
Z-1434-2019	Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218	N/A	Class II	Terminated	29 May 2019
Z-1435-2019	Drill, cannulated, 4x120mm, AO, Item Number 502015402	N/A	Class II	Terminated	29 May 2019
Z-1436-2019	Drill, cannulated, 4x150mm, AO, Item Number 502015403	N/A	Class II	Terminated	29 May 2019
Z-1437-2019	Drill, cannulated, 2x95mm, round shaft, Item Number 502015619	N/A	Class II	Terminated	29 May 2019
Z-1438-2019	Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620	N/A	Class II	Terminated	29 May 2019
Z-1439-2019	Drill, cannulated, 2.5x95mm, AO, Item Number 502015621	N/A	Class II	Terminated	29 May 2019
Z-1440-2019	Drill, cannulated, 2x95mm, AO, Item Number 502015623	N/A	Class II	Terminated	29 May 2019
Z-1441-2019	Drill, cannulated, 2.8x120mm, AO, Item Number 502015628	N/A	Class II	Terminated	29 May 2019
Z-1442-2019	Drill, cannulated, 2.8x150mm, AO, Item Number 502015629	N/A	Class II	Terminated	29 May 2019
Z-1443-2019	Drill, cannulated, 3x90mm, round shaft, Item Number 502015630	N/A	Class II	Terminated	29 May 2019
Z-1444-2019	Drill, cannulated, 3x90mm, AO, Item Number 502015631	N/A	Class II	Terminated	29 May 2019
Z-1445-2019	V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634	N/A	Class II	Terminated	29 May 2019
Z-1446-2019	Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635	N/A	Class II	Terminated	29 May 2019
Z-1447-2019	V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636	N/A	Class II	Terminated	29 May 2019
Z-1448-2019	V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637	N/A	Class II	Terminated	29 May 2019
Z-1449-2019	V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638	N/A	Class II	Terminated	29 May 2019
Z-1450-2019	Drill, cannulated, 4x90mm, round shaft, Item Number 502015640	N/A	Class II	Terminated	29 May 2019
Z-1451-2019	Drill, 3.2x145mm, AO, Item Number 502015650	N/A	Class II	Terminated	29 May 2019
Z-1452-2019	Drill, contra-angle, 1.5x85mm, Item Number 502015706	N/A	Class II	Terminated	29 May 2019
Z-1453-2019	CBS 7.5 tap, cannulated, AO, Item Number 503002041	N/A	Class II	Terminated	29 May 2019
Z-1454-2019	MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177	N/A	Class II	Terminated	29 May 2019
Z-1455-2019	CBS micro, countersink, cannulated, round-shaft, Item Number 503004341	N/A	Class II	Terminated	29 May 2019
Z-1456-2019	CBS high, countersink, cannulated, round-shaft, Item Number 503004342	N/A	Class II	Terminated	29 May 2019
Z-1457-2019	CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351	N/A	Class II	Terminated	29 May 2019
Z-1458-2019	CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352	N/A	Class II	Terminated	29 May 2019
Z-1459-2019	CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353	N/A	Class II	Terminated	29 May 2019
Z-1460-2019	CBS micro, countersink, cannulated, AO, Item Number 503004541	N/A	Class II	Terminated	29 May 2019
Z-1461-2019	CBS high, countersink, cannulated, AO, Item Number 503004542	N/A	Class II	Terminated	29 May 2019
Z-1462-2019	V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110	N/A	Class II	Terminated	29 May 2019
Z-1463-2019	V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111	N/A	Class II	Terminated	29 May 2019
Z-1464-2019	V-TEK", micro-countersink, round shaft, Item Number 28.66.112	N/A	Class II	Terminated	29 May 2019
Z-1465-2019	V-TEK", Micro-countersink, AO, Item Number 28.66.113	N/A	Class II	Terminated	29 May 2019
Z-1466-2019	V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111	N/A	Class II	Terminated	29 May 2019
Z-1467-2019	V-TEK", Micro-countersink, AO , Item Number ST28.66.113	N/A	Class II	Terminated	29 May 2019
Z-1468-2019	Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number ST502015206	N/A	Class II	Terminated	29 May 2019
Z-1469-2019	Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207	N/A	Class II	Terminated	29 May 2019
Z-1470-2019	Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208	N/A	Class II	Terminated	29 May 2019
Z-1471-2019	Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212	N/A	Class II	Terminated	29 May 2019
Z-1472-2019	Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216	N/A	Class II	Terminated	29 May 2019

Showing 60 of 76 product records; the FDA enforcement report lists all of them.

Context

88%of 2019 device events are Class II968 events that year

76product records in this eventfirm median: 1

14events on this register for the firm

Other enforcement events for Zimmer GmbH

Initiated	Product (first record)	Type	Class	Records
8 Aug 2024	Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or no	Device	Class II	2
7 May 2021	Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for tempor	Device	Class II	2
21 Aug 2019	Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem	Device	Class II	1
31 Oct 2018	Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller St	Device	Class II	1
15 Mar 2018	Normed Charcot Osteotome Chisel (Various sizes)	Device	Class II	1
28 Feb 2018	Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368	Device	Class II	2
11 May 2017	Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersi	Device	Class II	1
30 Jun 2016	Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or	Device	Class II	1
27 Jun 2016	TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and ha	Device	Class II	4
17 May 2016	Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects	Device	Class II	1

All 14 events for Zimmer GmbH

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 11 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.