Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail (RH 130 DEG 9MM X 380MM) distributed nationwide in the US as well as in Portugal and the Netherlands. During a rework process related to an earlier field action from April 17, 2017, the set screw and sleeve assembly—which are designed to fit together tightly—were found to be missing from their installed location. This defect could prevent the product from assembling properly with the mating screw and targeting jig.
The affected devices are identified by Item No. 814509380 and include three lot numbers with expiration dates ranging from May 21, 2027, to June 13, 2027 (lot numbers 507130, 892880, and 893400). The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Reason for recall: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig. Distribution: US nationwide distribution. Also Portugal and the Netherlands. Quantity: 638 units Lot/code info: Item No. 814509380; Lot No. (Exp. Date) UDI: 507130 (05/21/2027) UDI (01)00887868038914 (17)270521 (10)507130; 892880 (06/13/2027) UDI (01)00887868038914 (17)270613 (10)892880; 893400 (06/13/2027) UDI (01)00887868038914 (17)270613 (10)893400
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.