Z-1099-2016Class II

Product 1 consists of all product under

Name: Z-1099-2016 Product 1 consists of all product under
Creator: Zimmer Manufacturing B.V.
Published: 2016-01-11
License: https://open.fda.gov/license/

Zimmer Manufacturing B.V. / initiated 2016-01-11 / Terminated / root cause: packaging

FDA source

Zimmer Manufacturing B.V. began a recall of Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded... on 2016-01-11. FDA classified it as Class II and gives the reason as "As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1099-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Posted: 2016-03-12
Terminated: 2017-04-13
Recalling firm: Zimmer Manufacturing B.V.
Product: Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Product code: HWC Screw, Fixation, Bone
Reason for recall: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Root cause tag: packaging
FDA root cause: Packaging
Action: Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to [email protected]. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
Quantity in commerce: 0
Distribution: US Nationwide Distribution
Product codes and lots: lot no.: 61889944

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1099-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1100-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1101-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1102-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1103-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1104-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1105-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1106-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1107-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1108-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1109-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1110-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1111-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1112-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1113-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1114-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1115-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1116-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1117-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1118-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1119-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1120-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1121-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1122-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1123-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1124-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1125-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1126-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1127-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1128-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1129-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1130-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1131-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1132-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1133-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1134-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1135-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1136-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1137-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1138-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1139-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1140-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1141-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1142-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1143-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1144-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1145-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1146-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1147-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1148-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1149-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1150-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1151-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1152-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1153-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1154-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1155-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1156-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1157-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1158-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1159-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1160-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1161-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1162-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1163-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1164-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1165-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1166-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1167-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1168-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1169-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1170-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12

Product code HWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)