Food, drugs, devices › Zimmer Manufacturing B.V.

Device recall: Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTap

FDA enforcement event 73981 · Class II · initiated 4 May 2016 · status Terminated · terminated 5 Jul 2017

DeviceVoluntary: Firm initiated12 product recordsMercedita, PR

FDA enforcement event 73981 is a device recall by Zimmer Manufacturing B.V. of Mercedita, PR, initiated 4 May 2016 and classified Class II, with 12 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 5 Jul 2017. Initiation: voluntary: firm initiated. Zimmer Manufacturing B.V. has 8 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 Manufacturing B.V., Mercedita, PR.

Reason for recall

"A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws."

Distribution

"Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1673-2016	Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 3.5 mm Cortical Screw SelfTapping, 30 mm Length…	794	Class II	Terminated	25 May 2016
Z-1674-2016	Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401	100	Class II	Terminated	25 May 2016
Z-1675-2016	Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801	200	Class II	Terminated	25 May 2016
Z-1676-2016	Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116	99	Class II	Terminated	25 May 2016
Z-1677-2016	Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 4.0 mm Cancellous Screw…	3955	Class II	Terminated	25 May 2016
Z-1678-2016	M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042	219	Class II	Terminated	25 May 2016
Z-1679-2016	Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini MagnaFx Cannulated Screw Fixation System Small…	751	Class II	Terminated	25 May 2016
Z-1680-2016	Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007	90	Class II	Terminated	25 May 2016
Z-1681-2016	ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745	50	Class II	Terminated	25 May 2016
Z-1682-2016	VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400	50	Class II	Terminated	25 May 2016
Z-1683-2016	Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii…	1199	Class II	Terminated	25 May 2016
Z-1684-2016	Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw 6.5x25 selftap 00625006525 Bone screw 6.5x30 selftap 00625006530	3893	Class II	Terminated	25 May 2016

Context

91%of 2016 device events are Class II1,232 events that year

12product records in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for Zimmer Manufacturing B.V.

Initiated	Product (first record)	Type	Class	Records
17 Mar 2016	Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in to	Device	Class II	2
11 Jan 2016	Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/	Device	Class II	72
3 Dec 2015	NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component	Device	Class II	1
2 Dec 2015	Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat	Device	Class II	1
4 Dec 2014	Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or un	Device	Class II	1
21 Nov 2014	Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The mu	Device	Class II	1
12 Jun 2014	Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and	Device	Class II	1

All 8 events for Zimmer Manufacturing B.V.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws."

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: "Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 5 Jul 2017. "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.